System for Medicinal Supply Monitoring and Management for Pooled Medicinal Product Across Studies

Abstract

A medicinal supply management system manages distribution of medicinal supply. The system may implement a pooling algorithm for pooling studies together, across different countries, with different protocol labeling parameters and/or blinding parameters. The system may allocate unique identifiers for the pooled studies. The system may implement digital display labels on the medicinal product for up-to-date presentation of relevant information to healthcare providers administering the medicinal product. The system may further implement controlled packaging for maintaining proper storage of the medicinal product, e.g., during transport to the treatment site. The controlled packaging may further include sensors for monitoring the internal environment of the controlled packaging, to maintain proper storage of the medicinal product.

What is claimed is: 
     
         1 . A computer-implemented method for management of pooled medicinal product across studies, the method comprising:
 pooling medicinal product across a plurality of clinical trial studies into one or more pools based on characteristics of the clinical trial studies;   allocating one or more batches of medicinal product to each pool of studies;   for each pool of studies, assigning a unique identifier to each medicinal product in the one or more batches of medicinal product allocated to the pool of studies;   receiving, from a treatment-site client device, an order request for a quantity of medicinal product;   identifying a first pool of studies associated with the treatment-site client device;   generating a fulfillment list of medicinal product selected from the one or more batches of medicinal product allocated to the first pool of studies; and   providing the fulfillment list for filling the order request.   
     
     
         2 . The computer-implemented method of  claim 1 , wherein pooling the medicinal product across the plurality of clinical trial studies comprises:
 identifying, for each clinical trial study, a set of one or more countries for conducting the clinical trial study;   identifying, for each country, protocol labeling parameters; and   pooling the medicinal product based on overlapping protocol labeling parameters between countries.   
     
     
         3 . The computer-implemented method of  claim 1 , wherein pooling the medicinal product across the plurality of clinical trial studies comprises:
 identifying, for each clinical trial study, blinding parameters; and   pooling the medicinal product based on the blinding parameters for the clinical trial studies.   
     
     
         4 . The computer-implemented method of  claim 1 , further comprising:
 applying a model to forecast demand for each pool of studies based on the clinical trial studies in the pool of studies,   wherein allocating the batches of medicinal product across the pools of studies is based on the forecasted demands for the pools of studies.   
     
     
         5 . The computer-implemented method of  claim 1 , further comprising:
 applying a model to forecast demand for a treatment site associated with the treatment-site client device based on participants enrolled at the treatment site;   wherein generating the fulfillment list of medicinal product comprises allocating an amount of medicinal product based on the forecasted demand for the treatment site.   
     
     
         6 . The computer-implemented method of  claim 1 , wherein, for each pool of studies, assigning the unique identifier to each medicinal product allocated to the pool of studies comprises random assignment of double permutated alphanumeric identifiers. 
     
     
         7 . The computer-implemented method of  claim 1 , further comprising:
 storing the unique identifiers for the medicinal product for each pool of studies in a database associated with one or more protocols for the clinical trial studies in the pool of studies.   
     
     
         8 . The computer-implemented method of  claim 7 , further comprising:
 receiving, via the treatment-site client device, an identifier for a participant and a first unique identifier for the medicinal product associated with the first pool of studies;   identifying that the participant is enrolled in a first study in the first pool of studies;   accessing the protocol associated with the first study from the database; and   transmitting, to the treatment-site client device, the protocol associated with the first study.   
     
     
         9 . The computer-implemented method of  claim 1 , further comprising:
 accessing a label image for inclusion on the medicinal product allocated to the first pool of studies; and   encoding the label image for presentation on digital display labels affixed to the medicinal product allocated to the first pool of studies.   
     
     
         10 . The computer-implemented method of  claim 9 , further comprising:
 identifying protocol labeling parameters associated with a first country where the treatment site is located,   wherein accessing the label image is based on the protocol labeling parameters associated with the first country.   
     
     
         11 . A non-transitory computer-readable storage medium storing instructions for management of pooled medicinal product across studies, the instructions that, when executed by a computer processor, cause the computer processor to perform operations comprising:
 pooling medicinal product across a plurality of clinical trial studies into one or more pools based on characteristics of the clinical trial studies;   allocating one or more batches of medicinal product to each pool of studies;   for each pool of studies, assigning a unique identifier to each medicinal product in the one or more batches of medicinal product allocated to the pool of studies;   receiving, from a treatment-site client device, an order request for a quantity of medicinal product;   identifying a first pool of studies associated with the treatment-site client device;   generating a fulfillment list of medicinal product selected from the one or more batches of medicinal product allocated to the first pool of studies; and   providing the fulfillment list for filling the order request.   
     
     
         12 . The non-transitory computer-readable storage medium of  claim 11 , wherein pooling the medicinal product across the plurality of clinical trial studies comprises:
 identifying, for each clinical trial study, a set of one or more countries for conducting the clinical trial study;   identifying, for each country, protocol labeling parameters; and   pooling the medicinal product based on overlapping protocol labeling parameters between countries.   
     
     
         13 . The non-transitory computer-readable storage medium of  claim 11 , wherein pooling the medicinal product across the plurality of clinical trial studies comprises:
 identifying, for each clinical trial study, blinding parameters; and   pooling the medicinal product based on the blinding parameters for the clinical trial studies.   
     
     
         14 . The non-transitory computer-readable storage medium of  claim 11 , the operations further comprising:
 applying a model to forecast demand for each pool of studies based on the clinical trial studies in the pool of studies,   wherein allocating the batches of medicinal product across the pools of studies is based on the forecasted demands for the pools of studies.   
     
     
         15 . The non-transitory computer-readable storage medium of  claim 11 , the operations further comprising:
 applying a model to forecast demand for a treatment site associated with the treatment-site client device based on participants enrolled at the treatment site;   wherein generating the fulfillment list of medicinal product comprises allocating an amount of medicinal product based on the forecasted demand for the treatment site.   
     
     
         16 . The non-transitory computer-readable storage medium of  claim 11 , wherein, for each pool of studies, assigning the unique identifier to each medicinal product allocated to the pool of studies comprises random assignment of double permutated alphanumeric identifiers. 
     
     
         17 . The non-transitory computer-readable storage medium of  claim 11 , the operations further comprising:
 storing the unique identifiers for the medicinal product for each pool of studies in a database associated with one or more protocols for the clinical trial studies in the pool of studies.   
     
     
         18 . The non-transitory computer-readable storage medium of  claim 17 , the operations further comprising:
 receiving, via the treatment-site client device, an identifier for a participant and a first unique identifier for the medicinal product associated with the first pool of studies;   identifying that the participant is enrolled in a first study in the first pool of studies;   accessing the protocol associated with the first study from the database; and   transmitting, to the treatment-site client device, the protocol associated with the first study.   
     
     
         19 . The non-transitory computer-readable storage medium of  claim 11 , the operations further comprising:
 accessing a label image for inclusion on the medicinal product allocated to the first pool of studies; and   encoding the label image for presentation on digital display labels affixed to the medicinal product allocated to the first pool of studies.   
     
     
         20 . The non-transitory computer-readable storage medium of  claim 19 , the operations further comprising:
 identifying protocol labeling parameters associated with a first country where the treatment site is located,   wherein accessing the label image is based on the protocol labeling parameters associated with the first country.